US9724203B2 - Porous tissue ingrowth structure - Google Patents

Abstract

A three-dimensional scaffold for a medical implant includes a plurality of layers bonded to each other. Each layer has a top surface and a bottom surface and a plurality of pores extending from the top surface to the bottom surface. Each layer has a first pore pattern of the pores at the top surface and a different, second pore pattern at the bottom surface. Adjacent surfaces of at least three adjacent layers have a substantially identical pore pattern aligning to interconnect the pores of the at least three adjacent layers to form a continuous porosity through the at least three adjacent said layers.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This is a non-provisional application based upon U.S. Provisional Patent Application Ser. No. 61/789,723, entitled “POROUS TISSUE INGROWTH STRUCTURE”, filed Mar. 15, 2013, which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to medical implants, and, more particularly, to medical implants having a bone and tissue ingrowth structure, and to a method of manufacturing the medical implants.

2. Description of the Related Art

Implant fixation via bone and tissue integration into a porous scaffold has been in development since the 1950s, when polyvinyl sponges were implanted into canines (Bryan, R. S., et al., “The Effect of Polyvinyl-Formal (Ivalon) Sponge on Cortical Bone Healing.”Proceedings of the Staff Meetings, Mayo Clinic,33 (1958): 453-457). The early 1970s saw the development of sintered beads and titanium fiber metal, which are still in use in orthopaedic implants today. (Galante, J., Et al., “Sintered Fiber Metal Composites as a Basis for Attachment of Implants to Bone.”Journal of Bone and Joint Surgery Am,563 (1971): 101-114).

In the Mid 1990s, a design was developed for porous scaffolds for tissue ingrowth. For example, U.S. Pat. No. 5,732,469 discloses a prosthesis for the replacement of hard tissues of human bones and joints formed by a porous lamination component of thin, metal layers, each of which have a different pore pattern. Further, U.S. Pat. No. 6,010,336 discloses a living body-supporting member having a porous surface layer formed of ceramic material. However, the scaffolds known in the art which are constructed to encourage bone ingrowth have reduced strength due to the low contact area between adjacent layers. More specifically, the weak points in laminate scaffolds known in the art are in the resulting layer interfaces between individual layers, especially in shear parallel to these interfaces. Accordingly, if the scaffold struts are too thin, the scaffold will not satisfy the necessary strength. Additionally, implants formed from the laminate of thin metal layers are costly to produce, since the scaffold's strength must be bolstered by increased minimum thickness of the layers.

What is needed in the art is a medical implant which has an improved strength, particularly shear strength in planes parallel to individual layers, and which may be manufactured in a cost-effective way.

SUMMARY OF THE INVENTION

The present invention provides a medical implant, and, more particularly, a medical implant having a bone and tissue ingrowth structure, as well as a method of manufacturing the medical implant.

The present invention in one form is directed to a three-dimensional scaffold for a medical implant including a plurality of layers bonded to each other, each layer having a top surface and a bottom surface. Each of the layers have a plurality of pores extending from the top surface to the bottom surface. Further, each layer has a first pore pattern of the plurality of pores at the top surface and a different, second pore pattern at the bottom surface. Adjacent surfaces of at least three adjacent of the layers have a substantially identical pore pattern aligning to interconnect the pores of the at least three adjacent layers to form a continuous porosity through the at least three adjacent said layers.

The invention in another form is directed to a medical implant including a main body and at least one three-dimensional scaffold coupled with the main body. The at least one scaffold includes a plurality of layers bonded to each other, each layer having a top surface and a bottom surface and a plurality of pores extending from the top surface to the bottom surface. Each layer has a first pore pattern of the pores at the top surface and a different, second pore pattern at the bottom surface. Adjacent surfaces of at least three adjacent layers have a substantially identical pore pattern aligning to interconnect the pores of the at least three layers and form a continuous porosity through the at least three adjacent said layers.

The present invention further provides a method of manufacturing a scaffold for a medical implant including the provision of a plurality of layers of a biocompatible material having a top surface and a bottom surface. A plurality of pores are created in the plurality of layers of biocompatible material such that each layer has a plurality of pores extending from the top surface to the bottom surface. A first pore pattern of the pores at the top surface of each of said layers is different than a second pore pattern at the bottom surface of each of the layers. The layers are bonded together such that adjacent surfaces of at least three adjacent layers have a substantially identical pore pattern aligning to interconnect the pores of the at least three adjacent layers, forming a continuous porosity through the at least three adjacent layers.

An advantage of the present invention is that, due to the alignment of the pore patterns, the strength of the produced three-dimensional scaffold is increased, especially shear strength in planes parallel to individual layers.

Another advantage is provided by the present invention since the alignment of the pore patterns further requires the alignment of the struts surrounding the pores at the adjacent surfaces of adjacent layers, more cost effective manufacturing is possible through reduction of the minimum strut thickness required. Additionally, the configuration and positioning of the layers forming the 3-dimensional scaffold according to the present invention provide for improved aesthetics of the resulting scaffold.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of an embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a top view of a single layer of a scaffold according to the present invention;

FIG. 2 is a sectional view of the single layer of a scaffold along the A-A line, illustrated inFIG. 1;

FIG. 3 is a top view of a scaffold for a medical implant according to the present invention;

FIG. 4 is a sectional view of the scaffold ofFIG. 3 along the A-A line;

FIG. 5 is a top view of a layer of a scaffold according to the present invention;

FIG. 6 is a sectional view of the layer of scaffold ofFIG. 5 along the A-A line;

FIG. 7 is a top view an additional embodiment of a layer of a scaffold according to the present invention;

FIG. 8 is a sectional view of the layer of scaffold ofFIG. 7 along the A-A line;

FIG. 9 is a sectioned perspective view of a medical implant according to the present invention;

FIG. 10 is a sectioned perspective view of an additional embodiment of a medical implant according to the present invention;

FIG. 11 is a sectioned side view of an additional embodiment of a scaffold according to the present invention;

FIG. 12 is a sectioned side view of the stiffening layer of the scaffold according to claim11; and

FIG. 13 is a sectioned side view of a further embodiment of a barrier layer for a scaffold according to the present invention;

FIG. 14 is a flow chart of a method of manufacturing a scaffold for a medical implant according to the present invention; and

FIG. 15 is a method of manufacturing a medical implant according to the present invention.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, and more particularly toFIGS. 1 and 2, there is shown asingle layer10 of a three-dimensional scaffold for a medical implant according to the present invention.Single layer10 includes a plurality of pores or through-holes12 defined by a plurality ofstruts14. The geometries of thepores12 vary through a thickness D of eachlayer10. Any layer thickness D can be used, for example layer thickness D may be in a range of, for example, between approximately 0.0001 inch (in) and 10 in, for example 0.0001 to 0.040 in, or 0.020 to 0.040 in. Further, struts14 are defined as bars of material extending between anddefining pores12. Eachlayer10 has a first pore pattern at atop surface16 and different, second pore pattern at an opposing,bottom surface18. Transition from the first pore pattern to the second pore pattern takes place at a location or transition point T, where T is defined by the equation T=A*D, with T being a defined distance from thetop surface16 oflayer10 toward thebottom surface18, and A representing a fraction of the thickness oflayer10. A is in a range of 0<A<1, for example, in a range between approximately 0.05 and 0.95, for example between approximately 0.35 and 0.65.

Layers10 are formed of biocompatible materials including metals, polymeric material and zirconia. Suitable metals include titanium and titanium alloys, tantalum and tantalum alloys, cobalt chrome alloys, stainless steel and alumina. Exemplary polymeric materials include polyaryletherketone (PAEK) polymers, such as polyetheretherketone (PEEK), polyetherketone (PEK), Polyetherketoneketone (PEKK), polyetherketone etherketone ketone (PEKEKK), polyethylene, polyurethane.

Referring now toFIGS. 3 and 4, there is shown a three-dimensional scaffold20, which resembles a rigid sponge, for a medical implant according to the present invention, including a plurality of thelayers10 ofFIG. 1 bonded to each other, one on top of another. Three-dimensional scaffold20 includes at least threelayers10, for example 4, 5, 6 or more layers. According to the present invention at least three of layers10 (10₁,10₂,10₃) have a first pore pattern attop surface16 and a second, different pattern atbottom surface18 and are positioned such that the pore patterns of respectiveadjacent surfaces16,18 of at least three adjacent layers are substantially identical, for example identical, and align with one another over the course of at the least three adjacent layers, for example 4, 5, or 6 or more adjacent layers. Thus, pores12 of each of the at least threelayers10 are interconnected with one another to form continuous porosity or path through the at least threelayers10. Due to the specified construct,scaffold20 is configured for facilitation of bone or tissue ingrowth.

Accordingly, an exemplary three-dimensional scaffold20 according to the present invention may have the following structure:

• • On layer I, the pore pattern on the top surface is Pore Pattern A, and the pore pattern on the bottom surface is Pore Pattern B.
  • On layer II, the pore pattern on the top surface is Pore Pattern B, and the pore pattern on the bottom surface is Pore Pattern C.
  • On layer III, the pore pattern on the top surface is Pore Pattern C, and the pore pattern on the bottom surface is Pore Pattern D.

Although the example above includes four pore patterns, it is feasible to have as few as two different pore patterns. It is also feasible to have more pore patterns, dependent upon the number oflayers10 formingscaffold20. Further, although the example set forth above includes only threelayers10, it is also feasible to include more than three layers inscaffold20. Any additionallayers forming scaffold20 may or may not be porous and, if they are porous, may or may have a pore pattern which matches up with the pore pattern of the adjacent surface of adjacent layer(s). For example, it is possible to have an additional, fourth layer having the same pore pattern as the adjacent surface, but not be aligned with the pore pattern of the adjacent surface. Alternatively, the pore pattern of an additional, fourth layer may have a different pore pattern than the adjacent surface(s) of the adjacent layer(s).

Since, the pore pattern of adjacent surfaces of adjacent layers mate up substantially identical to each other through at least threeadjacent layers10 of aninventive scaffold20, the contact area of thestruts14 is high at the adjacent surfaces of these adjacent layers. The weak points of thescaffold20 are thereby moved to the inside of theindividual layers10 rather than the interfaces betweenlayers10 and the tolerance of the strut width can be increased. In other words, the strut width can be decreased, thereby maximizing the potential porosity and pore interconnectivity, while maintaining or improving the strength of thestrut14, and the thereby formedscaffold20.

Referring now toFIG. 5, there is shown an embodiment of alayer10 for ascaffold20 which includespores12 having at least two different geometries as they progress fromtop surface16 tobottom surface18 oflayer10.Pores12 oflayer10 forscaffold20 according to the present invention may, however, include any number of different geometries, for example 2, 3, 4 or more different geometries as thepores12 progress fromtop surface16 tobottom surface18.

Referring now toFIG. 6, there is shown a sectional view oflayer10 along line A-A ofFIG. 5 having more than two different pore patterns through thickness D oflayer10, which extends betweentop surface16 andbottom surface18.Layer10 thus includes two transition points T₁and T₂, thereby including a first pore pattern attop surface16, a second pore pattern which initiates at first transition point T₁, and a third pore pattern which initiates at second transition point T₂and extends tobottom surface18. In other words, in the example shown inFIG. 6, the first pore pattern extends betweentop surface16 and first transition point T₁, the second pore pattern extends between first transition point T₁and second transition point T₂, and the third pore pattern extends between second transition point T₂andbottom surface18. In this example, first transition point T₁is determined by the equation T₁=A*D, wherein A is a fraction between 0 and 1 and D is the thickness oflayer10, which extends betweentop surface16 andbottom surface18. Further, second transition point T₂is determined by the equation T₂=B*D, wherein B is a fraction between 0 and 1 of layer thickness D. In this example, the values for A and B are such that 0<A<B<1.

According to a further embodiment of the scaffold according to the present invention, there may be provided interlocking features22 that increase strength, most notably shear strength. For example, interlocking features22 may be configured to allow adjacent layers to nest together. Once they are stacked, they may then be bonded together to form three-dimensional scaffold20. For example, referring now toFIGS. 7 and 8, there is shown an embodiment of asurface16 or18 oflayer10 according to the present invention where interlocking features22 are in the form of a plurality ofundercuts22 formed insurface16 or18 oflayer10.FIG. 8 is a sectional view along line A-A ofFIG. 7, which illustrates an exemplary undercut22 according to the present invention in relation tostruts14 andpores12 oflayer10.Undercuts22 have a depth M relative to the thickness D oflayer10, wherein depth M is a fraction of the thickness D, and thus M=C*D, with C being a predetermined fraction of D, and C being between 0 and 1.Undercuts22 can be formed on one or both sides of eachlayer10 ofscaffold20. Further, corresponding projections (not shown) on another layer may be used to seat another layer within undercuts22 on anadjacent layer10. If projections are not used, then struts14 of anadjacent layer10 can seat within corresponding undercuts22. These undercuts22 thus are interlockingfeatures22 which lock onelayer10 together with anadjacent layer10.

Referring now toFIGS. 11 and 12,scaffold20 may further include at least onestiffening layer24 in the form of a rigid, solid material. Stiffeninglayer24 may be positioned on an outside surface, for example abottom surface18, oflayers10 solely for purposes of providing additional strength and support to scaffold20, and/or may be positioned to separatescaffold20 into multiple regions. Stiffeninglayer24 provides added strength and rigidity, for example, when a medical implant is formed including the scaffolding and, for example, an additional solid body. In such a case, stiffeninglayer24 provides added rigidity during, for example injection molding, thereby helping to resist deformation during manufacture while injection forces are high. Additionally, stiffeninglayer24 prevents the flow of material from one region through to another region on an opposite side of stiffeninglayer24.

Additionally, at least onestiffening layer24 may be connected to another body, for example a solid body or anotherscaffold20 according to the present invention with at least one alignment and/orfixation device30, for example fixation pins, spikes, stakes or screws. For example, fixation pins30 can be press-fit intostiffening layer24 to hold the components in place for purposes of injection molding of an additional body to form a desired implant. Further, stiffeninglayer24 advantageously provides an indicator for implant orientation when viewed via MRI, CT, or X-ray. Stiffeninglayer24 may be formed of any biocompatible metal or polymer/plastic, such as, but not limited to, titanium, tantalum, or PEEK.

For exemplary purposes,scaffold20 may include stiffeninglayer24 which separates a porousbone ingrowth region26 formed fromlayers10 and a porous polymer retention orpoly retention region28, also formed fromlayers10. Stiffeninglayer24 is, for example, formed from a solid, non-porous layer, thereby providing a fluid barrier betweenbone ingrowth region26 andpoly retention region28. Advantageously,bone ingrowth region26 provides a roughened surface for initial implant stability, and later, with bone ingrowth, long term stability, whilepoly retention region28 provides a series ofinterconnected pores12 and channels for polymeric material, such as PEEK, to flow therethrough for purposes of forming an interlocking anchor, locking the PEEK to the scaffold material.

A further embodiment of stiffeninglayer24 includes pores25 which do not extend through the entire thickness oflayer24, thereby preventing fluid flow through from alayer10 on one side of stiffeninglayer24 to anotherlayer10 on an opposing side of stiffeninglayer24. Stiffeninglayer24 may further include a pore pattern on each side, which does not extend through an entire thickness ofstiffening layer24 such that there is no fluid flow path from one side oflayer24 through to the other side oflayer24, as is illustrated inFIGS. 11 and 12. Stiffeninglayer24 can be manufactured, for example by stamping, photochemical etching, laser etching, machining, micro-milling, or electron beam machining, to name a few.

Alternatively, according to another embodiment of thescaffold20 according to the present invention, there may be included twoadjacent layers10 having adjacent surfaces which have pore patterns formed such that there is no interconnectivity ofpores12 of the surfaces of the adjacent layers, as illustrated atFIG. 13. Thus, although the pores can go all the way through each respective layer, there is no fluid flow path between the respective layers. Thus, solid areas of one layer, in the form of struts, block the path formed by the pores in the adjacent layer, thereby forming a fluid barrier. According to this embodiment of the present invention, aseparate stiffening layer24 is not necessary since the twoadjacent layers10 are aligned such that there is no fluid flow path between the pores of onelayer10 to theadjacent layer10, thereby forming a fluid barrier. Methods of manufacturing andbonding layers10 together are disclosed in U.S. Patent Application Publication Nos. 2010/0042167, 2010/0042218 and 2010/0042215, which are incorporated in their entireties herein by reference.

Referring now toFIGS. 9 and 10, there is shown amedical implant40 according to the present invention.Medical implant40 generally includes amain body42 and aninsert44 formed of ascaffold20 coupled withmain body42.

Medical implant40 is shown inFIGS. 9 and 10 as an implant for any of a number of, for example, spinal inter-body devices used in different spinal surgical approaches, for example anterior cervical devices (cervical devices inserted from different orientations), lumbar and thoracic lumbar implants. The referenced cervical devices are typically inserted into the disc space of the cervical spine after the damaged or degenerated disc is removed. As shown inFIG. 10,medical implant40 may also havegrooves46 formed in at least one, for example 2 surfaces. The grooves help to prevent back-out or expulsion ofimplant40 after implantation. However, it also may be utilized in a number of other device applications, for example glenoid or acetabular implants (porous material may only be attached to one side of these devices), High Tibial Osteotomy (HTO) implants, and so on.

Medical implant40 incorporatesscaffold20, as set forth more fully above, including a plurality oflayers10 bonded to each other and having atop surface16 and abottom surface14. Each oflayers10 has a plurality ofpores12 extending fromtop surface16 tobottom surface18. A pore pattern of thepores12 ontop surface16 of each oflayers10 is different than a pore pattern onbottom surface18.Pores12 ofadjacent surfaces16,18 of at least threeadjacent layers10 have a substantially identical pore pattern over the course of at least threeadjacent layers10.Medical implant30 may have 1 ormore scaffolds20, for example 2, 3, 4 or more scaffolds, which provide one or more roughened, porous surfaces onmedical implant40 for bone ingrowth. Eachscaffold20 ofimplant30 is formed, for example of a biocompatible metal, such as titanium and titanium alloys, aluminum and aluminum alloys, and titanium-cobalt alloys.Scaffolds20 ofimplant40 may also be formed of a biocompatible polymeric material, for example a PAEK, such as PEEK, PEK, PEKK, or PEKEKK.

In the embodiment illustrated inFIGS. 9 and 10,main body42 is positioned between twoadjacent scaffolds20, thereby providing, for example, a porous ingrowth surface on two opposing sides ofimplant30 or, in the alternative, aporous ingrowth region26 on one side and a poly-retention region28 on an opposing side. In this case, for example, cephalad and caudal surfaces each have roughened surface for initial stability. The cephalad and caudal surfaces ofimplant40 are thereby porous in nature to allow and encourage bone to grow into these surfaces, improving long-term fixation.

Main body32 is formed, for example, of a biocompatible metal, plastic, polymeric material, or ceramic material. Suitable metals include titanium and titanium alloys, tantalum and tantalum alloys, cobalt chrome alloys, and stainless steel. Exemplary polymeric materials are, for example, a thermoplastic polymer that is non-resorbable and substantially inert, such as polyetheretherketone (PEEK). PEEK is especially suited for orthopaedic applications since it has a modulus of elasticity similar to that of bone, is resistant to compressive loading, has a high biocompatibility and biostability, and due to its radiolucency.

Referring now toFIG. 14, the present invention further provides amethod50 for manufacturing ascaffold20 for a medical implant according to the present invention. According toinventive method50, a plurality of layers of a biocompatible material having a top surface and a bottom surface are provided, as indicated atstep52. According to the present invention, layers10 formed of different materials may be utilized to formscaffold20. For example, titanium layers and PEEK layers may be assembled to form three-dimensional scaffold20.

A plurality of pores are created in the layers of biocompatible material such that at least some of the pores, for example all of the pores, extend from the top surface to the bottom surface and a pore pattern of the pores on the top surface is different than another pattern on the bottom surface, as indicated atstep54. According to one embodiment of the method for manufacturing a scaffold according to the present invention, pores are, for example, created in a respective layer from both sides, namely, from the top surface and from the bottom surface. Additional methods for creatingpores12 inlayers10 include, but are not limited to, chemical etching, photochemical etching, laser cutting, electron-beam machining, conventional machining, stamping, extrusion, rolling and knurling.

According to the present invention, different patterns are used to create pores on each side of a respective layer.Method50 further provides forstep56, which includes bonding a plurality of the layers together to form a three dimensional scaffold such that adjacent top surfaces and bottom surfaces of respective adjacent layers have a substantially identical pore pattern aligning over the course of at least three adjacent layers.Bonding step56 may be completed using diffusion bonding, sintering, laser welding, heat staking, thermal processing, ultrasonic welding, mechanical fastening, and/or adhesive bonding.

Ifscaffold20 further includes astiffening layer24, all of the above-described layers of biocompatible material having the defined pore pattern may be first assembled together and bonded prior tobonding stiffening layer24 thereto. Alternatively, stiffeninglayer24 may be positioned at a predetermined position within the plurality of layers prior to bonding and thereafter bonded together in a single step. Regardless of which method of construction is utilized, if the material ofscaffold20 is a metal or a plurality of metals, for example titanium, then diffusion bonding can be used to bond the components ofscaffold20 together. Alternatively, sintering can be utilized to complete the bonding step. If the material of any of the components of the scaffold is a polymer, then heat staking can be used to bond the polymer components together. It is also possible to utilize a combination of diffusion bonding and heat staking, dependent upon the material(s) utilized, for example a combination of polymer materials and metal materials.

Referring now toFIG. 15, there is shown amethod60 of forming a medical implant, which includes thestep62 of providing at least onescaffold20, for example twoscaffolds20, which may be manufactured according to the method set forth above according to the present invention. Scaffold(s)20 may include stiffening layer(s)24, as set forth above. When two ormore scaffolds20 are utilized,method60 provides for interconnection of thescaffolds20 with a plurality of fixation devices, for example fixation pins, which are press fit betweenscaffolds20 to securely affix eachscaffold20 into place. It is also feasible to provide a combination of alignment and fixation pins, each being press fit intoscaffolds20, connecting and aligningscaffolds20 with each other.

A main body is then coupled64 withscaffolds20. Main body can be made from a variety of materials, including titanium and a cobalt/chromium alloy, and PEEK, among other materials. Couplingstep64 may be completed using diffusion bonding, mechanical fasteners, and injection molding. For example,scaffolds20 are loaded into a mold and PEEK is injected (or alternatively heated and pressed) betweenscaffolds20, filling the space therebetween to form a medical implant.Scaffolds20 included herein not only have a porous ingrowth region, but also a porous polymer retention (poly-retention) region that allows the polymer, for example PEEK, to flow into and anchor the polymer, fusing the polymer to thescaffold20 as the polymer cures. Stiffeninglayer24 provide rigidity for thescaffold20 during formation of the medical implant during the molding process. The process of injection molding employs a substantial amount of force to inject the polymer, therefore this stiffening layer helps the insert or scaffold to hold its form while the polymer is injected.

While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claims (21)

What is claimed is:

1. A three-dimensional scaffold for a medical implant, the scaffold comprising a plurality of layers bonded to each other and each said layer having a top surface and a bottom surface, each of said layers having a plurality of pores extending through said top surface to said bottom surface, each said layer having a first pore pattern of said plurality of pores at said top surface and a different, second pore pattern at said bottom surface, said first pore pattern and said second pore pattern partially overlapping within each said layer, wherein adjacent said surfaces of at least three adjacent said layers having a substantially identical pore pattern aligning to interconnect said plurality of pores of said at least three adjacent layers and form a continuous porosity through said at least three adjacent said layers.

2. The scaffold according toclaim 1, each of said plurality of layers having at least one transition point where a geometry of said plurality of pores extending between said top surface and said bottom surface transitions from said first pore pattern to at least one said second pore pattern, said at least one transition point being at a position in a range between approximately 0.05 and 0.95 through a thickness of said respective layer.

3. The scaffold according toclaim 2, wherein said at least one transition point is two transition points.

4. The scaffold according toclaim 3, said thickness of each of said plurality of layers being in a range between approximately 0.0001 and 10 inches.

5. The scaffold according toclaim 2, wherein different said pores of said plurality of layers have a plurality of different geometries.

6. The scaffold according toclaim 1, wherein said plurality of layers of the scaffold include at least one interlocking feature allowing adjacent said layers to nest together.

7. The scaffold according toclaim 6, wherein said interlocking feature is at least one undercut in at least one of said plurality of layers into which extends one of a strut of an adjacent one of said plurality of layers and a protrusion extending from said adjacent one of said plurality of layers.

8. A medical implant, comprising:

a main body; and

at least one scaffold coupled with said main body, said at least one scaffold including a plurality of layers bonded to each other, each said layer having a top surface and a bottom surface and a plurality of pores extending through said top surface to said bottom surface, each said layer having a first pore pattern of said plurality of pores at said top surface and a different, second pore pattern at said bottom surface, said first pore pattern and said second pore pattern partially overlapping within each said layer, wherein adjacent said surfaces of at least three adjacent said layers having a substantially identical pore pattern aligning to interconnect said plurality of pores of said at least three layers and form a continuous porosity through said at least three adjacent said layers.

9. The medical implant according toclaim 8, wherein said main body is formed of a solid material.

10. The medical implant according toclaim 9, wherein said solid material is one of an implantable polymer material and a solid metal.

11. The medical implant according toclaim 10, wherein said implantable polymer material is polyetheretherketone (PEEK).

12. The medical implant according toclaim 8, said at least one scaffold being formed of an implantable metal material.

13. The medical implant according toclaim 8, wherein the medical implant is an implantable spinal device.

14. The medical implant according toclaim 13, said at least one scaffold further comprising a plurality of anti-back out grooves.

15. The medical implant according toclaim 14, said at least one scaffold further comprising a solid, stiffening layer, wherein said at least one scaffold is at least two scaffolds including at least one first scaffold and at least one second scaffold, said stiffening layer being positioned between said at least one first scaffold and said at least one second scaffold, sealing said at least one first scaffold from said at least one second scaffold.

16. The medical implant according toclaim 15, said stiffening layer being formed from one of a biocompatible metal and a polymeric material.

17. The medical implant according toclaim 16, wherein said stiffening layer has a pair of opposing surface, at least one of said opposing surfaces of said stiffening layer including a plurality of surface pores which do not extend through an entire thickness of said stiffening layer.

18. The medical implant according toclaim 17, wherein said opposing surfaces of said stiffening layer include first surface and a second surface, each of said first surface and said second surface of said stiffening layer including a plurality of surface pores, said stiffening layer including a solid region between said surface pores of said opposing surfaces to prevent flow through from said first surface of said stiffening layer to said second surface of said stiffening layer.

19. The medical implant according toclaim 18, further comprising at least one alignment pin for holding said stiffening layer in position.

20. The medical implant according toclaim 8, wherein said plurality of layers is at least four layers and one layer of said at least four layers is configured such that a plurality of solid regions of said one layer abut said plurality of pores of an adjacent one of said plurality of layers to prevent flow through between said one layer and an adjacent layer of said at least four layers.

21. A method of manufacturing a scaffold for a medical implant, the method comprising the steps of:

providing a plurality of layers of a biocompatible material having a top surface and a bottom surface;

creating a plurality of pores in said plurality of layers of biocompatible material such that each of said layers has a plurality of pores extending through said top surface to said bottom surface, a first pore pattern of said plurality of pores at said top surface of each of said layers being different than a second pore pattern of said bottom surface of each of said layers, and said first pore pattern and said second pore pattern partially overlap within each said layer; and

bonding said plurality of layers together such that adjacent said surfaces of at least three adjacent said layers have a substantially identical pore pattern aligning to interconnect said plurality of pores of said at least three layers forming a continuous porosity through said at least three adjacent said layers.

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